Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q1 2022 Earnings Presentation
24 slides from Acadia Pharmaceuticals's earnings presentation, May 4, 2022
Slide 1: First Quarter 2022 Earnings Call
First Quarter 2022 Earnings Call May 4, 2022
Slide 2: 1Q22 Earnings Call Agenda
1Q22 Earnings Call Agenda Introduction Mark Johnson | Vice President, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Commercial Update Brendan Teehan | Chief Operating Officer, Head of Commercial R&D Update Serge Stankovic, M.D., M.S.P.H | President Financial Update Mar
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future r
Slide 4: CEO Opening Remarks
CEO Opening Remarks Steve Davis CEO
Slide 5: Acadia's Growth Strategy
Acadia’s Growth Strategy Drive Growth of Advance Three Late-Stage Develop the Next Wave NUPLAZID® Franchise Opportunities of Breakthroughs Building a Leading CNS Company NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for the treatment of hallucinations and delusions associated with
Slide 6: Drive Growth of NUPLAZID in PDP
Drive Growth of NUPLAZID® in PDP 1Q22 • Delivered net sales of $115.5M, increase of 8% YoY • Similar rate of demand growth to what we experienced in 2021 Looking • NUPLAZID has continued its strong outperformance Ahead • NUPLAZID growth to accelerate when Parkinson’s disease (PD) market growth rates
Slide 7: Resubmitted sNDA of Pimavanserin for ADP
Resubmitted sNDA of Pimavanserin for ADP Advisory Committee on June 17, 2022 | Target Action Date of August 4, 2022 1 Efficacy: Pimavanserin has shown consistent and clinically meaningful improvement in the symptoms of psychosis and a reduction of relapse risk in Alzheimer’s disease patients 1 2 Saf
Slide 8: Advancing Late-Stage Opportunities
Advancing Late-Stage Opportunities NDA for Rett syndrome Phase 3 NSS Program (Trofinetide) (Pimavanserin) • FDA aligned with contents of NDA submission based • Positive pivotal study, ADVANCE-1, already complete on pivotal Lavender study • Evaluating 34 mg dose of pimavanserin in second • NDA submis
Slide 9: Develop the Next Wave of Breakthroughs
Develop the Next Wave of Breakthroughs Program Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed NUPLAZID® Parkinson’s Disease (pimavanserin)1 Psychosis Alzheimer’s Disease Pimavanserin2 Psychosis Trofinetide3 Rett Syndrome Negative Symptoms of Pimavanserin Schizophrenia Postoperative and ACP-
Slide 10: Commercial Update
Commercial Update Brendan Teehan Chief Operating Officer, Head of Commercial
Slide 11: NUPLAZID Growth and PD Market Dynamics
NUPLAZID Growth and PD Market Dynamics • Delivered net sales of $115.5M, increase of 8% YoY • Driven by 4% demand growth, in-line with FY22 net sales guidance NUPLAZID • Recent HCP and patient/caregiver campaigns generated demand growth • Focus on top prescribers and top LTC facilities • PD Market g
Slide 12: Alzheimer's Disease Psychosis (ADP)
Alzheimer’s Disease Psychosis (ADP) ADP represents a significant unmet medical need • ADP market ~7X the size of PDP market size No approved treatments, with marginal efficacy and known safety issues with currently used off-label, multi-receptor acting antipsychotics Well-prepared to execute commerc
Slide 13: Trofinetide for Rett Syndrome
Trofinetide for Rett Syndrome Significant Unmet Need: • No FDA-approved treatment • 6,000 to 9,000 patients in the U.S.1 ➢ NDA Submission Planned for mid-22; ➢ Potential PDUFA in 1Q23 Market Preparation: HCP Feedback Caregiver Feedback Patients and Physicians Very high percentage of physicians would
Slide 14: R&D Update
R&D Update Serge Stankovic President
Slide 15: Pimavanserin for the Treatment of ADP
Pimavanserin for the Treatment of ADP High Unmet Need1: Pimavanserin for ADP in Clinical Studies • No FDA-approved treatment • HARMONY Study3: Clinically meaningful reduction • ~900K ADP patients treated w/ in risk of relapse of psychosis in ADP subgroup off-label drugs in the U.S. (n=123; ~40% redu
Slide 16: Trofinetide for Treatment of Rett Syndrome
Trofinetide for Treatment of Rett Syndrome Proposed Mechanism of Action: Pivotal Lavender Study Results • Novel synthetic analog of amino‐terminal tripeptide of IGF-1 • Co-Primary Endpoints: Statistically significant separation from placebo; RSBQ • Potential to reduce neuroinflammation (p=0.0175), C
Slide 17: Pimavanserin for the Treatment of the Negative Symptoms of Schizophrenia
Pimavanserin for the Treatment of the Negative Symptoms of Schizophrenia High Unmet Need1: ADVANCE-1 Results2 • No FDA-approved treatment • Primary endpoint: Improvement in NSA-16 • >700K patients receiving treatment in the U.S. have compared to placebo at 26 weeks (p=0.043) persistent negative symp
Slide 18: Early-Stage Pipeline Opportunities
Early-Stage Pipeline Opportunities ACP-044 program with ongoing chronic osteoarthritis pain study Phase 2 ACP-319 lead compound from M1 PAM program licensed from Vanderbilt Phase 1 Collaboration with Stoke Therapeutics focused on development of ASO Preclinical preclinical programs for SYNGAP1, Rett,
Slide 19: Finance Update
Finance Update Mark Schneyer Chief Financial Officer
Slide 20: 1Q22 Financial Highlights
1Q22 Financial Highlights Millions, Except EPS 1Q22 1Q21 YoY Change (GAAP) (GAAP) Total Revenue $115.5 $106.6 +8% R&D $128.9 $57.0 +126% SG&A $96.7 $111.7 -13% Net Loss $113.1 $66.4 +70% EPS ($0.70) ($0.42) -67% Cash Balance1 $446.0 1Cash balance includes cash, cash equivalents and investments as of
Slide 21: FY22 Financial Guidance - Reiterated
FY22 Financial Guidance - Reiterated FY22 Guidance Commentary • Midpoint reflects similar demand growth rate to 2021 NUPLAZID® Net Sales $510 to $560M • PDP related revenue only • ~$60M related to Stoke collaboration in 1Q22 GAAP R&D Expense $355 to $375M • ~$25M of stock-based compensation expense
Slide 22: CEO Closing Remarks
CEO Closing Remarks Steve Davis CEO
Slide 23: Significant Growth Opportunities
Significant Growth Opportunities PDP FY22 Guidance = Significant opportunity for accelerated long-term growth Commercial $510 - $560M ADP Action date for pimavanserin sNDA resubmission August 4, 2022 Resubmission Trofinetide for Trofinetide NDA submission for Rett syndrome Mid-22 Rett Syndrome Negat
Slide 24: Q&A Session
() ACADIA Q&A Session
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